The Influence of Sensory Stimuli on Gait Imagery in Patients With Freezing of Gait
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 3/24/2019 |
| Start Date: | February 1, 2010 |
| End Date: | January 3, 2014 |
Background:
- Freezing of gait (FOG) is a common and very disabling symptom in people with Parkinson s
disease, significantly affecting their quality of life. It has been defined as a sudden break
or block in the walking motion, or as an inability to start walking. Although certain neural
connections or neurological processes might contribute to FOG, more research is needed to
produce consistent findings. Researchers are interested in investigating brain function
involved in FOG.
Objectives:
- To obtain more information on brain function in individuals with freezing of gait.
Eligibility:
- Individuals between the ages of 45 and 80 who have been diagnosed with Parkinson s
disease.
- Participants must be willing to go off their current Parkinson s disease medications for
up to 12 hours at a time.
Design:
- Participants will be divided into two groups: those who do have freezing of gait (more
than about once a day) and those who have not experienced this symptom.
- The study will involve a screening visit (1 hour) and a study visit (2 hours).
- During the screening visit, participants will be asked about medical history, and will
have physical, neurological, memory, and walking tests.
- Participants should not take their Parkinson's disease medications for 12 hours before
the study visit. Participants who cannot come to the clinic safely without their
medications will be allowed to stay in the hospital overnight before the visit, and
should bring their medications to the study in order to take them as soon as needed
after the study.
- Participants will be asked to perform several tasks before the imaging study: (1)
walking 10 yards back and forth down a hallway, (2) walking 10 yards back and forth
while following horizontal lines on the floor, (3) walking 10 yards back and forth while
listening to a metronome, and (4) being pushed back and forth in a wheelchair.
- After participants perform the actual tasks, participants will be asked to imagine
performing the tasks and fill out questionnaires about how well they can imagine the
tasks.
- Participants will be monitored with a functional magnetic resonance imaging (fMRI) scan
while imagining the four tasks they have just performed.
- Freezing of gait (FOG) is a common and very disabling symptom in people with Parkinson s
disease, significantly affecting their quality of life. It has been defined as a sudden break
or block in the walking motion, or as an inability to start walking. Although certain neural
connections or neurological processes might contribute to FOG, more research is needed to
produce consistent findings. Researchers are interested in investigating brain function
involved in FOG.
Objectives:
- To obtain more information on brain function in individuals with freezing of gait.
Eligibility:
- Individuals between the ages of 45 and 80 who have been diagnosed with Parkinson s
disease.
- Participants must be willing to go off their current Parkinson s disease medications for
up to 12 hours at a time.
Design:
- Participants will be divided into two groups: those who do have freezing of gait (more
than about once a day) and those who have not experienced this symptom.
- The study will involve a screening visit (1 hour) and a study visit (2 hours).
- During the screening visit, participants will be asked about medical history, and will
have physical, neurological, memory, and walking tests.
- Participants should not take their Parkinson's disease medications for 12 hours before
the study visit. Participants who cannot come to the clinic safely without their
medications will be allowed to stay in the hospital overnight before the visit, and
should bring their medications to the study in order to take them as soon as needed
after the study.
- Participants will be asked to perform several tasks before the imaging study: (1)
walking 10 yards back and forth down a hallway, (2) walking 10 yards back and forth
while following horizontal lines on the floor, (3) walking 10 yards back and forth while
listening to a metronome, and (4) being pushed back and forth in a wheelchair.
- After participants perform the actual tasks, participants will be asked to imagine
performing the tasks and fill out questionnaires about how well they can imagine the
tasks.
- Participants will be monitored with a functional magnetic resonance imaging (fMRI) scan
while imagining the four tasks they have just performed.
Objective
Freezing of gait (FOG) is a common and very disabling symptom in Parkinson s disease (PD). It
has been defined as a sudden transient break (motor block) in the walking motion or as an
inability to generate effective stepping. It significantly affects PD patients, resulting in
a decline in Quality of Life (QOL). Although certain neural substrates or neuronal
connectivity might contribute to FOG, no consistent findings have been established. Our major
goal is to investigate the pathophysiology of the brain as it relates to FOG.
Study population
We intend to study 46 PD patients (23 with freezing and 23 without).
Design
Assuming that certain neural networks or brain regions are associated with FOG, we are
planning to investigate its mechanism by measuring the Blood Oxygen Level Dependent (BOLD)
effect with functional MRI (fMRI) during motor imagery (MI) of gait in PD patients with and
without FOG, and compare the results with each other.
Using a block design in functional magnetic resonance imaging (fMRI), we will examine brain
activity and brain connectivity of PD patients with and without freezing while they execute
four tasks: normal gait imagery; gait imagery with lines on the floor (visual cue); gait
imagery with sounds of the metronome (auditory cue); and imagery of being moved by the
experimenter while sitting in a wheelchair. The last condition is done to control for the
visual flow which should be experienced during MI of gait.
It is known that the motor ability of PD patients, both those with and without FOG, improves
with exposure to certain visual stimuli. Using a treadmill combined with a virtual reality
environment, we will test the effect of different visual stimuli on the gait performance of
PD subjects with and without FOG. In particular, we will examine gait performance as it
relates to FOG.
Outcome Measures
For the fMRI experiment, the primary outcome measure is the change of BOLD-MRI signals and
the functional connectivity of the activated regions during different conditions and between
groups. In addition, the Vividness of Movement Imagery Questionnaire (VMIQ) score (Isaac A,
1986) will also be collected as a secondary outcome measure.
Another secondary outcome measure involves the treadmill experiment. In this test, the
outcome measure is the motion analysis data, such as stride length and speed, which are
derived from the VICON system. Using this test, we hope to determine when the FOG phenomenon
occurred.
Freezing of gait (FOG) is a common and very disabling symptom in Parkinson s disease (PD). It
has been defined as a sudden transient break (motor block) in the walking motion or as an
inability to generate effective stepping. It significantly affects PD patients, resulting in
a decline in Quality of Life (QOL). Although certain neural substrates or neuronal
connectivity might contribute to FOG, no consistent findings have been established. Our major
goal is to investigate the pathophysiology of the brain as it relates to FOG.
Study population
We intend to study 46 PD patients (23 with freezing and 23 without).
Design
Assuming that certain neural networks or brain regions are associated with FOG, we are
planning to investigate its mechanism by measuring the Blood Oxygen Level Dependent (BOLD)
effect with functional MRI (fMRI) during motor imagery (MI) of gait in PD patients with and
without FOG, and compare the results with each other.
Using a block design in functional magnetic resonance imaging (fMRI), we will examine brain
activity and brain connectivity of PD patients with and without freezing while they execute
four tasks: normal gait imagery; gait imagery with lines on the floor (visual cue); gait
imagery with sounds of the metronome (auditory cue); and imagery of being moved by the
experimenter while sitting in a wheelchair. The last condition is done to control for the
visual flow which should be experienced during MI of gait.
It is known that the motor ability of PD patients, both those with and without FOG, improves
with exposure to certain visual stimuli. Using a treadmill combined with a virtual reality
environment, we will test the effect of different visual stimuli on the gait performance of
PD subjects with and without FOG. In particular, we will examine gait performance as it
relates to FOG.
Outcome Measures
For the fMRI experiment, the primary outcome measure is the change of BOLD-MRI signals and
the functional connectivity of the activated regions during different conditions and between
groups. In addition, the Vividness of Movement Imagery Questionnaire (VMIQ) score (Isaac A,
1986) will also be collected as a secondary outcome measure.
Another secondary outcome measure involves the treadmill experiment. In this test, the
outcome measure is the motion analysis data, such as stride length and speed, which are
derived from the VICON system. Using this test, we hope to determine when the FOG phenomenon
occurred.
- INCLUSION CRITERIA:
1. PD patients with freezing:
1. 40 to 80 years of age with idiopathic PD
2. Hoehn and Yahr stage 1-4
3. Answer to the FOGQ item 3 range from 3-4 (freezing more than about once a
day).
4. Existence of FOG documented by a neurologist
5. Currently taking medications for PD such as L-DOPA (Sinemet) or dopamine
agonists such as Mirapex or ReQuip.
6. Willing and able to be off your PD medications for at least 12 hours for
visit 1 and visit 2.
2. PD patients without freezing:
1. 40 to 80 years of age with idiopathic PD
2. Hoehn and Yahr stage 1-4
3. Answer to the FOG item 3 is 0 (Never freezes).
4. The lack of existence of FOG documented by a neurologist.
5. Currently taking medications for PD such as L-DOPA (Sinemet) or dopamine
agonists such as Mirapex or ReQuip.
6. Willing and able to be off your PD medications for at least 12 hours on one
occasion.
Patients in the FOG group and the non-FOG group will be matched by clinical disease stage.
EXCLUSION CRITERIA:
1. Any active psychiatric disease or evidence of dementia
2. Feel uncomfortable being in small, enclosed spaces (claustrophobia) or unable to lie
still for an hour, e.g. due to back pain
3. Pallidotomy or implanted electrodes and generator for deep brain stimulation
4. Pregnancy
5. Surgically or traumatically implanted foreign bodies such as a pacemaker, implanted
medical pump, implanted hearing aids, metal plate in the skull, or metal implant in
the skull or eyes (other than dental appliances or fillings) that may pose a physical
hazard during MRI.
6. Inability to provide informed consent
7. Unable to walk a 10 meter distance even with help of an assisting device
8. Unable or unwilling to withhold PD medications for 12 hours prior to visit 1 and visit
2
9. Have a neurologic condition other than PD, such as a brain tumor, stroke, head trauma
or a vascular malformation
10. Have a dysfunction of vision, such as severe loss of visual acuity, that impairs
his/her ability to perform the visual imagery task or to appreciate the virtual
reality environment during the treadmill test
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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